Data / Medical devices / Powered Laser Surgical Instrument With MicrobeamFractional Output / United States
FDA-registered makers of Powered Laser Surgical Instrument With MicrobeamFractional Output in the United States: 13 establishments
13 establishments in the United States are registered with the FDA to make Powered Laser Surgical Instrument With MicrobeamFractional Output (product code ONG). 6 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- Powered Laser Surgical Instrument With MicrobeamFractional Output
- Product code
- ONG
- Country
- United States
Makers of Powered Laser Surgical Instrument With MicrobeamFractional Output in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Manufacturer, Manufacturer for export, Repackager or relabeler | 4 | January 2, 2024 | 0 | 0 | 0 | api.fda.gov |
| Solta Medical, Inc. | Bothell, WA, United States | Manufacturer, Remanufacturer, Specification developer | 4 | April 2, 2012 | 0 | 0 | 0 | api.fda.gov |
| Avava, Inc. | Waltham, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | November 21, 2022 | 0 | 0 | 0 | api.fda.gov |
| Focus Medical, LLC. | Bethel, CT, United States | Manufacturer | 1 | April 12, 2012 | 0 | 0 | 0 | api.fda.gov |
| Paradigm Medical Technologies Corporation | San Diego, CA, United States | Complaint file establishment, Specification developer | 1 | June 3, 2022 | 0 | 0 | 0 | api.fda.gov |
| Tria Laser Inc | Livermore, CA, United States | Specification developer | 1 | October 25, 2013 | 0 | 0 | 0 | api.fda.gov |
| Acclaro Corporation | Smithfield, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolase MG LLC | Corona, CA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Biolase MG LLC | Foothill Ranch, CA, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RH Usa, Inc. | Livermore, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sciton, Inc. | Palo Alto, CA, United States | Complaint file establishment, Manufacturer, Remanufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina | San Jose, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.